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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION CORPORATION DAILIES AQUACOMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR

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CIBA VISION CORPORATION DAILIES AQUACOMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number A0478438
Device Problems Entrapment of Device (1212); Product Quality Problem (1506); Torn Material (3024)
Patient Problems Corneal Ulcer (1796); Inflammation (1932); Foreign Body In Patient (2687)
Event Date 06/11/2017
Event Type  Injury  
Manufacturer Narrative
The actual complaint product was not returned for evaluation. The device history record and sterilization record for this lot have been reviewed and found to be in compliance. There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint. The root cause could not be determined. (b)(4).
 
Event Description
It was initially reported by a consumer on 06/12/2017 that five contact lenses were torn during wear. It was reported by the consumer that upon removal of the contact lenses she could only take out either a torn piece of the contact lens or half of the contact lens. It was reported by the consumer that once she had to go to an eye care provider (ecp) due to an unspecified inflammation and an unspecified ulceration but the treatment modality and duration was not known. It was reported by the consumer that the ecp has removed the remaining part of the torn contact lens out of her eye. Additional information received from the consumer via email on 06/22/2017 stating that the eye inflammation and corneal ulcer happened on (b)(6) 2017. It was reported by the consumer that the left eye was involved and that it was "ulcerous". The consumer reported that she uses ¿levothyroxine sodium + liothyronine sodium¿ and an unspecified antibiotic drops as treatment, however the frequency and duration of both treatments are unknown. It was reported by the consumer that the event has resolved and that she is able to wear contact lenses again without problems. Additional information received from the consumer via email on 06/23/2017 clarifying that four contact lenses were torn during wear. No further information will be made available as the consumer refused to be contacted again.
 
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Brand NameDAILIES AQUACOMFORT PLUS
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION CORPORATION
11460 johns creek parkway
duluth GA 30097
Manufacturer (Section G)
CIBA VISION CORPORATION
11460 johns creek parkway
duluth GA 30097
Manufacturer Contact
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6702481
MDR Text Key79655355
Report Number1065835-2017-00020
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K072777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Patient
Type of Report Initial
Report Date 07/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2021
Device Lot NumberA0478438
Other Device ID NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/11/2017 Patient Sequence Number: 1
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